Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-04-09 @ 11:53 PM
Study NCT ID:
NCT01875302
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2013-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions
Sponsor:
nSpire Health, Inc.
Organization:
Study Overview
Official Title:
Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol defines the requirements to demonstrate that the PRO instruments which were designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All validation studies of the questionnaires were conducted using the original paper versions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: